IMPORTANT WARNING:

Important warning for older adults with dementia:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as aripiprazole have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or ministroke or other severe side effects during treatment.

Aripiprazole is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking aripiprazole. For more information visit the FDA website: http://www.fda.gov/Drugs.

Important warning for people who have depression:

A small number of children, teenagers, and young adults (up to 24 years of age) who took medications for depression during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take aripiprazole to treat depression, but in some cases, a doctor may decide that aripiprazole is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take aripiprazole or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and mania (frenzied, abnormally excited mood). Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking aripiprazole, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with aripiprazole. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Why is this medication prescribed?

Aripiprazole is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used alone or with other medications to treat episodes of mania or mixed episodes (symptoms of mania and depression that happen together) in adults, teenagers, and children 10 years of age and older with bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Aripiprazole is also used with an antidepressant to treat depression when symptoms cannot be controlled by the antidepressant alone. Aripiprazole is also used to treat children 6 to 17 years of age who have autistic disorder (a developmental problem that causes difficulty communicating and interacting with others). Aripiprazole may help control irritable behavior such as aggression, temper tantrums, and frequent mood changes in these children. Aripiprazole is also used to treat children 6 to 18 years of age who have Tourette's disorder (a condition characterized by the need to perform repeated motions or to repeat sounds or words). Aripiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

How should this medicine be used?

Aripiprazole comes as a tablet, a solution (liquid), an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken once a day with or without food. Apriprazole also comes as a tablet that contains a sensor device to take by mouth to be used in adults to provide information about how the medication is taken. Take aripiprazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take aripiprazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not try to push the orally disintegrating tablet through the foil. Instead, use dry hands to peel back the foil packaging. Immediately take out the tablet and place the entire tablet on your tongue. Do not try to split the tablet. The tablet will quickly dissolve and can be swallowed without liquid. If necessary, liquid can be used to take the orally disintegrating tablet.

Swallow the tablets and the tablet with a sensor whole; do not divide, crush, or chew.

The tablets that contain a small sensor come with a patch (a wearable sensor) that detects a signal from the tablet and a smartphone application (app) to display information about how you are taking the medication. The app must be downloaded onto your smartphone before you start the medication. Apply your patch to the left side of the body above the lower edge of the rib cage only when prompted by the smartphone app instructions. Do not place the patch in areas where the skin is scraped, cracked, inflamed, or irritated or in a location that overlaps the area of the most recently removed patch. Change the patch weekly or sooner, if needed. The app reminds you to change the patch and explains how to apply and remove the patch correctly. Keep the patch on when showering, swimming, or exercising. If undergoing a magnetic resonance imaging (MRI; a medical test that uses powerful magnets to take pictures of the inside of the body), remove the patch and replace it with a new one as soon as possible. If the patch causes skin irritation, remove it and tell your doctor. After you take the medication, the tablets can be detected in the body by the app within 30 minutes to 2 hours. If the tablet is not detected after ingestion, do not take another dose. Talk to your doctor if you have any questions about how to take the tablets and use the patch or smartphone app.

Your doctor may start you on a low dose of aripiprazole and gradually increase or decrease your dose depending on how well the medication works for you and the side effects you experience.

Aripiprazole may help control your symptoms but will not cure your condition. It may take 2 weeks or longer before you feel the full benefit of aripiprazole. Continue to take aripiprazole even if you feel well. Do not stop taking aripiprazole without talking to your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking aripiprazole,

tell your doctor and pharmacist if you are allergic to aripiprazole, any other medications, or any of the ingredients in aripiprazole preparations. Ask your doctor or pharmacist or check the Medication Guide for a list of the ingredients.

tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants (mood elevators); antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole; antihistamines; bupropion (Wellbutrin); clarithromycin (Biaxin); fluoxetine (Prozac, Sarafem); HIV protease inhibitors such as atazanavir (Reyataz), efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase); ipratropium (Atrovent); medications for anxiety, high blood pressure, irritable bowel syndrome, mental illness, motion sickness, Parkinson's disease, ulcers, or urinary problems; lorazapam (Ativan); nefazodone; paroxetine (Paxil, Pexeva); pioglitazone (Actos, in Oseni); quinidine (in Nuedexta); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sedatives; certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol, others), phenobarbital, and phenytoin (Dilantin, Phenytek); sleeping pills; telithromycin (Ketek; no longer available in U.S.); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with aripiprazole, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

tell your doctor what herbal products you are taking, especially St. John's wort.

tell your doctor if you have severe diarrhea or vomiting or you think you may be dehydrated. . Also tell your doctor if you have or have ever had heart disease, heart failure, a heart attack, an irregular heartbeat, high or low blood pressure, a stroke, a ministroke, seizures, a low number of white blood cells, dyslipidemia (high cholesterol levels), trouble keeping your balance, or any condition that makes it difficult for you to swallow. Tell your doctor if you or anyone in your family use or have ever used street drugs or have overused prescription medication or alcohol or has or has ever had diabetes, obsessive compulsive disorder, impulse-control disorder, bipolar disorder, or an impulsive personality. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.

tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking aripiprazole, call your doctor. Aripiprazole may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aripiprazole.

you should know that aripiprazole may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking aripiprazole.

you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking aripiprazole or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking aripiprazole: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

you should know that aripiprazole may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking aripiprazole. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

you should know that aripiprazole may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.

if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the orally disintegrating tablets contain phenylalanine. If you have diabetes, you should know that aripiprazole solution contains sugar.

you should know that some people who took medications such as aripiprazole developed gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors, excessive shopping, and binge eating. Call your doctor if you have intense urges to shop, eat, have sex, or gamble, or you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors such as have become a problem.

you should know that when aripiprazole is used to treat children, it should be used as part of a treatment program that may include counseling and special education. Be sure that your child follows all of his or her doctor's or therapist's instructions.

What special dietary instructions should I follow?

Talk to your doctor about drinking grapefruit juice while taking this medicine.

Be sure to drink plenty of water every day while you are taking this medication.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Aripiprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

headache

nervousness

restlessness

dizziness, feeling unsteady, or having trouble keeping your balance

heartburn

constipation

diarrhea

stomach pain

weight gain

changes in appetite

increased salivation

pain, especially in the arms, legs, or joints

tiredness

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section or the SPECIAL PRECAUTIONS section, call your doctor immediately:

Aripiprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets, the solution, and the orally disintegrating tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the orally disintegrating tablets in their sealed package, and use them immediately after opening the package. Store the tablets with a sensor at room temperature; do not store in places with high humidity. Dispose of any unused aripiprazole solution 6 months after you open the bottle or when the expiration date marked on the bottle has passed, whichever is sooner.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

drowsiness

weakness

widened pupils (black circles in the middle of the eyes)

nausea

vomiting

changes in heartbeat

movements that you cannot control

confusion

seizures

loss of consciousness

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order laboratory tests before and during your treatment with aripiprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.